FDA puts compounding pharmacies on hot seat

In its letters to CCS Medical and RoTech Healthcare, the FDA specifically cited the companies for manufacturing several inhalation products that were the same or very close in strength and formula to commercially available products. According to the FDA, RoTech's Pulmo-Dose subsidiary manufactures budesonide inhalation products in 0.4-mg and 0.3-mg vials, even though there is an FDA-approved, commercially available budesonide product (Pulmicort, AstraZeneca) available in strengths of 0.5 mg and 0.25 mg.

The FDA also alleged that CCS Medical produced compounded albuterol 0.0417% and 0.045% in 3-ml vials, while commercially available products are 0.042% in 3-ml vials. "We are not aware of any legitimate medical need for these insignificant differences in formulation," stated Carol A. Heppe, FDA district director in one of the warning letters.

Nancy Sander, president and founder of the Allergy & Asthma Network Mothers of Asthmatics, hailed the FDA warnings. "Patients have the right to expect that when a prescription is filled for Pulmicort, they are going to get that medication," she told Drug Topics. "We will continue to put pressure on the FDA to enforce the warning letters. This should not be the end, it should be the beginning. The companies should be warning the patients, not just physicians."

While the FDA letters focused on specific practices at the companies, the agency also issued a broadly worded assertion about the practice of compounding that has raised the concern of some pharmacy industry experts. "All compounded prescription drugs are 'new drugs' within the meaning of the Federal Food, Drug, and Cosmetic Act," the FDA asserted. "When a pharmacist compounds a prescription drug, by definition, he or she creates a new drug under federal law because the compounded product is not generally recognized, among experts ... as safe and effective."

"The FDA knows that requiring compounded drugs to be approved by the FDA is impractical," noted Joshua Wenderoff, a spokesman for the International Academy of Compounding Pharmacists (IACP). "It is an unacceptable position for the FDA to put us in, and we don't think Congress gave the FDA that power."

Others raised the concern that the FDA approach implies that all compounding is illegal. "Compounding based on a valid prescription from a licensed physician is the essence of pharmacy," insisted John Rector, senior VP for government affairs at the National Community Pharmacists Association.

Both Rector and Wenderoff expressed surprise that the FDA letters did not acknowledge a summary judgment rejecting its position in the case Medical Center Pharmacy et al. v. Gonzalez. In May, in a federal district court case brought by 10 Texas R.Ph.s, the court ruled that compounded drugs are not new drugs as the FDA contended. The court has yet to rule on the other issues in the case regarding unauthorized inspections and compounding from bulk ingredients.